Effect of Vitamin D Supplementation in Young Children With Acute Lower Respiratory Tract Infection at Dr George Mukhari Academic Hospital, Pretoria, South Africa
试验速览
- 阶段
- 4 期
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Comparison of change from baseline in modified Respiratory Distress Assessment Instrument score at hospital discharge between vitamin D supplement and placebo groups.
研究概览
简要总结
The purpose of this study is to determine whether vitamin D supplements given to children aged 1 month to 5 years, hospitalized with acute lower respiratory tract infection will improve symptoms and reduce the duration of hospitalization.
详细描述
In a randomized, double blind placebo controlled interventional study, children aged 1 month to 5 years, who are admitted with acute lower respiratory tract infection (ALRTI) to Dr George Mukhari Academic Hospital will be enrolled. The children will randomized to receive 2500 IU of vitamin D or a placebo. It is intended to enrol 320 children, 160 to receive vitamin D and the other 160 to receive a placebo. This sample size was calculated at 80% power and 5% significance. The children will be enrolled within 24 hours of admission and the intervention (supplement or placebo) will be daily until the child is discharged fron the hospital.
The severity of ALRTI will be assessed using the modified Respiratory Distress Assessment Instrument (MRDAI) score. The thorough physical examination and classification of severity of the symptoms will be done at enrolment and daily until hospital discharge.
Blood samples for vitamin D and calcium concentrations will be assessed at enrolment, before the child is given the supplement or placebo.
The difference in the improvement in MRDAI score between the placebo and the supplement will be assessed by analysis of variance (ANOVA). Similarly the difference in duration of hospital stay between the two groups will also be analysed using ANOVA. The association between the vitamin D levels and the MRDAI score on admission will also be assessed and analysed using ANOVA.
All eligible children will be sequentially enrolled until the desired sample size is reached. A simple randomisation by means of computer generated numbers will be used to minimize selection bias. Both the study subjects and the investigators will be blinded to the allocation (treatment or placebo). The unblinding will be done only after the analysis has been completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children age 1month - 5 yrs, admitted in the paediatric unit of Dr George Mukhari Hospital with an acute lower respiratory tract infection i.e. bronchiolitis and/ or pneumonia
排除标准
- •Children whose caregivers decline participation in the study Children with co-morbid chronic respiratory condition(s) Children who have received vitamin D supplementation in the past 30 days
研究组 & 干预措施
Vitamin D
Vitamin D 2 500 IU daily from enrolment until hospital discharge
干预措施: Vitamin D (Drug)
结局指标
主要结局
Comparison of change from baseline in modified Respiratory Distress Assessment Instrument score at hospital discharge between vitamin D supplement and placebo groups.
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 7 days
The modified Respiratory Distress Assessment Instrument score, involves the measurement of the child's respiratory rate, assessment of the use of accessory muscles, the child's color, and auscultatory findings; each of these is given a score from 0 to 3. The higher the score the more severe the clinical condition. This scoring system has been validated in a number of scientific studies.
次要结局
- Comparison of duration of hospitalization between vitamin D supplementation and placebo groups.(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
研究者
Siyazi Mda
Research project supervisor
University of Limpopo